title: What the ANPRM missed: additional needs for IRB reform.
abstract: Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.
authors.affiliation: Center for Mental Health Services at the University of Massachusetts Medical School, Worcester, MA, USA.
authors.forename: Charles W
authors.initials: CW
authors.lastname: Lidz
authors.forename: Suzanne
authors.initials: S
authors.lastname: Garverich
mesh_terms: D016494:Computer Security; D003625:Data Collection; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D017712:Peer Review, Research; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014481:United States